Medical catheter with balloon leakage indicator



1969 A. HARAUTUNEIAN MEDICAL CATHETER WITH BALLOON LEAKAGE INDICATOR Filed Oct. 10, 1966 FIG. 2.

v ATTORNEY United States Patent Office 3,426,758 Patented Feb. 11, 1969 3,426,758 MEDICAL CATHETER WITH BALLOON LEAKAGE INDICATOR Andrew Harautuneian, Gardena, Calif., assignor, by mesne assignments, to American Hospital Supply Corporation, a corporation of Illinois Continuation-impart of application Ser. No. 267,723, Mar. 25, 1963. This application Oct. 10, 1966, Ser. No. 585,636 US. Cl. 128349 6 Claims Int. Cl. G01d 21/00; A61m 25/00 This application is a continuation-in-part of my copending applications entitled Method of Catheter Manufacture, Ser. No. 267,723, and now United States Patent No. 3,304,353, and Catheter, Ser. No. 267,724 and now US. Patent No. 3,292,627, both of which were filed Mar. 25, 1963.

Balloon catheters for insertion through a patients urethral canal and into his bladder are comprised of a dual lumen tube with an inflatable retention balloon attached thereto. One lumen of the tube drains liquid through the catheter from the patient and the second lumen communicates with the balloon through an opening in the catheter wall through which liquid is forced to inflate the balloon.

These catheters often remain in a patient for several days and there is a problem of determining if the balloon (hidden from view) is inflated or has broken or leaked. With a deflated balloon the catheter can work its way out of the urethral canal or be pulled out by the patient moving about in his bed.

To overcome this disadvantage in balloon catheters it has been proposed to form one or more separate indicator balloons communicating with the inflation lumen at an opposite end of the catheter from the main retention balloon. Thus, if the inflation liquid leaks out of the main retention balloon, pressure within the rubber indicator balloons will drop, causing them to shrink.

These indicator balloons have many disadvantages. First, they are expensive to form. Secondly, if the tiny inflation lumen becomes plugged, the indicator balloon could remain inflated when the main retention balloon was deflated, thus giving a false indication of the retention balloons condition.

It is an object of this invention to provide at very little cost a unique reliable way of indicating if a retention catheters balloon (hidden from view) has burst or is leaking.

My invention is particularly suited for incorporation in a catheter described in the above copending applications which has an aqueous soluble partitioning coating encased between a transparent plastic tube and a transparent plastic balloon. The present invention has a colored dye encased between the balloon and tube prior to inflation of the balloon.

Perhaps my invention can be better understood with reference to the accompanying drawings, in which:

FIGURE 1 is a side elevational view of a proximate end of the catheter with a portion of the balloon area cut away to expose a partitioning coating; and

FIGURE 2 is a fragmentary view of the inflated catheter in a patients body cavity hidden from the view of a nurse or physician, with the catheter balloon shown in section.

The catheter comprises an elongated flexible tube 1 preferably of a transparent thermoplastic such as polyvinyl chloride, polyurethane, or polyethylene. Tube 1 has a wall defining a main drainage lumen 2 which terminates in a drainage port 5 adjacent a rounded nose 6 at proximate end 7 of the catheter. The wall of tube 1 also defines an inflation lumen 3 which communicates with an exterior surface of the tube wall through an inflation opening 4.

An aqueous soluble cylindrical partitioning coating 10 extending between ends 13 and 14 covers the tube 1 adjacent inflation opening 4. This partitioning coating 10 has an aqueous dispersible nontoxic colored dye integral therewith. In a catheter used as a urethral catheter this colored dye 1.1, such as a vegetable dye, has a color contrasting with the color of the patients urine 15.

An elastic balloon layer 20, preferably of a transparent thermoplastic material, surrounds the aqueous soluble partitioning coatinglO and has ends 21 and '22 bonded to tube 1 beyond ends 13 and 14 of partitioning coating 10. I have found that a poly(ester-urethane) such as Goodrich Chemical Companys Estane #5740x1 works very well for the balloon.

The colored dye 11 in the partitioning coating 10 encased between tube 1 and balloon layer 20, also serves to indicate if the partitioning coating is continuous about the tube .1 and is free of pinholes after manufacture. The completed catheter in the fragmentary view illustrated in FIGURE 1 can be supplied to a hospital or doctors otfice sterile and ready to use.

When the physician or nurse catheterizes a patient with this catheter, he inserts the proximate end 7 along the patients urethral canal v16 and into his bladder 17 filled with urine 15, as shown in FIGURE 2. Next, he injects water 24 from the catheters distal end through inflation lumen 3 and into the balloon. This water dissolves partitioning coating .10 and disperses the colored dye 11 throughout the balloon. Should the balloon develop a leak 23 or break, the colored dye 11 will show up in the urine 15 drained from tube 1. Although this colored dye 11 can be observed in a transparent connecting tube attached to a distal end of the catheter, it is preferable that the catheter tube .1 itself is transparent so colored dye 11 is immediately visible as it comes from the patient. In very small size catheters, it is also possible to observe some seepage of the dye 11 along urethral canal 16 outside catheter tube 1. Such seepage shows up on a bedsheet to show the balloon is leaking or has burst.

In the foregoing specification and drawings, I have described a unique catheter with a balloon leakage indicator. This balloon catheter is completely sterilized and sent from the manufacturer to a hospital or doctors otfice. In use, all that need be done is to inflate the balloon with water in the conventional way. There is no need for elaborate and costly secondary indicator balloons as in the prior art.

I have used a specific embodiment to illustrate my invention. However, it is understood that certain modifications to this embodiment can be made by those skilled in the art without departing from the spirit and scope of this invention.

I claim:

1. A medical catheter comprising:

(a) a flexible thermoplastic tube with a wall defining a main drainage lumen extending from a distal end to a proximate end, which proximate end is adapted for insertion through a body canal of a patient and into a body cavity hidden from view, and with a port adjacent the proximate end thereof, which fluid can enter the main drainage lumen, said flexible thermoplastic tube having associated therewith an inflation lumen extending longitudinally along said tube wall with the inflation lumen communicating with an exterior surface of the tube wall through an inflation p (b) a partitioning coating surrounding an exterior surface area of the tube wall about said inflation opening;

(c) a nontoxic aqueous dispersible colored dye integrally carried by said partitioning coating; and

(d) an elastic thermoplastic balloon layer bonded to the tube beyond ends of said coating and encasing said coating between said balloon layer and said tube, said partitioning coating being completely and totally dissolved in an aqueous inflating liquid introduced through said inflation lumen and inflation opening to expand said balloon layer, with the colored dye dispersed throughout the aqueous inflation liquid to indicate any leakage of the balloon layer, whereby completely dissolved coating material and dispersed colored dye can exit through said inflation opening and along the inflation lumen upon deflation of said balloon layer.

2. A medical catheter as set forth in claim 1 wherein the elastic thermoplastic balloon layer is transparent so the colored dye can give a visual indication of continuity and position of said partitioning coating.

3. A medical catheter as set forth in claim 1 wherein the flexible thermoplastic tube is transparent to give a visual indication of the aqueous dispersed colored dye in the main drainage lumen, thus indicating a leaking balloon.

4. In a medical catheter having an elongated tube with a wall defining two longitudinal lumens therein, one lumen communicating with an exterior surface of the tube through an inflation opening, which catheter has an inflatable elastic balloon layer surrounding the tube with opposite ends of the balloon layer bonded to the tube walls outer surface on opposite sides of the inflation opening, the improvement comprising a nontoxic colored dye integrally encased between the balloon and tube prior to inflation of the balloon, said colored dye being dispersible throughout an inflation media used to inflate the balloon, whereby the colored dye draining out of the catheter gives a visual indication of balloon leakage.

5. The improvement in a medical catheter as set forth in claim 4 wherein the tube is transparent.

6. The improvement in a medical catheter as set forth in claim 5 wherein the balloon layer is transparent.

References Cited UNITED STATES PATENTS 2,473,742 6/ 1949 Auzin 128-349 3,292,627 12/ 1966 Harautuneian l28349 3,361,547 l/1968 Pack-o 116-114 3,373,735 3/1968 Gallagher 128349 CHARLES F. ROSENBAUM, Primary Examiner.

US. Cl. X.R. 

4. IN A MEDICAL CATHETER HAVING AN ELONGATED TUBE WITH A WALL DEFINING TWO LONGITUDINAL LUMENS THEREIN, ONE LUMEN COMMUNICATING WITH AN EXTERIOR SURFACE OF THE TUBE THROUGH AN INFLATION OPENING, WHICH CATHETER HAS AN INFLATABLE ELASTIC BALLOON LAYER SURROUNDING THE TUBE WITH OPPOSITE ENDS OF THE BALLOON LAYER BONDED TO THE TUBE WALL''S OUTER SURFACE ON OPPOSITE SIDES OF THE INFLATION OPENING, THE IMPROVEMENT COMPRISING A NONTOXIC COLORED DYE INTEGRALLY ENCASED BETWEEN THE BALLOON AND TUBE PRIOR TO INFLATION OF THE BALLOON, SAID COLORED DYE BEING DISPERSIBLE THROUGHOUT AN INFLATION MEDIA USED TO INFLATE THE BALLOON, WHEREBY THE COLORED DYE DRAINING OUT OF THE CATHETER GIVES A VISUAL INDICATION OF BALLOON LEAKAGE. 